BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2965203 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-91128
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE CAMPUS NURSE AND THEY CALLED THE PARAMEDICS DUE TO HER BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER EXPERIENCED NAUSEA, BURNING, AND CAN NOT CONCENTRATE. THE CUSTOMER'S BLOOD GLUCOSE WAS 518MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD A NO DELIVERY ALARM BEFORE GOING TO WORK, AND SHE THOUGHT SHE ADJUSTED IT. IT WAS ALSO MENTIONED THAT THE CUSTOMER HAD HIGH POTASSIUM. IT WAS STATED THAT THE CUSTOMER IS FRIGHTENED AFTER BEING HOSPITALIZED, AND SINCE SHE WAS SICK THE FIRST WEEK SHE WAS ON THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66481 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization